Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K895442
Device Name THE X-RAY DIGITIZER, ALTEK MODEL ACT20020-BL
Applicant
Altek Corp.
12210 Plum Orchard Dr.
Silver Spring,  MD  20904
Applicant Contact THOMAS A RAINONE
Correspondent
Altek Corp.
12210 Plum Orchard Dr.
Silver Spring,  MD  20904
Correspondent Contact THOMAS A RAINONE
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received09/08/1989
Decision Date 12/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-